PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN

Description of Event or Problem

IT WAS REPORTED THAT THE TIP FROM THE ZIMMER PULSAVAC PLUS POPPED OFF DURING SURGERY. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT DURING AN ABDOMINAL SURGICAL PROCEDURE, THE FAN SPRAY TIP FELL OFF AFTER COMING IN CONTACT WITH THE TISSUE. THE TIP WAS RETRIEVED AFTER MINOR MANUAL EXPLORATION OF THE CAVITY. THERE WAS NO IMPACT TO THE PROCEDURE, PATIENT OR USER AS A RESULT OF THE TIP FALLING OFF. THE PROCEDURE WAS COMPLETED USING THE SAME PULSAVAC, WHICH WAS DISCARDED AFTERWARDS.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND THERE WERE NO NONCONFORMANCES DURING MANUFACTURE THAT WOULD BE RELATED TO THIS COMPLAINT. ALL TESTING REQUIREMENTS WERE MET. THE CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED.